The following data is part of a premarket notification filed by Abracadabra Implants Ltd with the FDA for Abc Dental Implant System.
Device ID | K202092 |
510k Number | K202092 |
Device Name: | ABC Dental Implant System |
Classification | Implant, Endosseous, Root-form |
Applicant | Abracadabra Implants Ltd 12 Hacharoshet St Or Yehuda, IL 6037580 |
Contact | Daniel Younisian |
Correspondent | Vladislav Dvoyris Blackwell Device Consulating 12 HaHaroshet St. IL 6037580 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-07-28 |
Decision Date | 2021-09-23 |